LATTITUDE PATIENT MANAGEMENT SYSTEM
FDA premarket approval P910077/S123 · decided 2012-09-25
Approval details
- PMA number
- P910077
- Supplement
- S123
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LATTITUDE PATIENT MANAGEMENT SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2012-07-27
- Decision date
- 2012-09-25
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE LATITUDE PATIENT MANAGEMENT SYSTEM APPLICATION SERVER SOFTWARE V7.03.0 1 ON LATITUDE SYSTEM SERVER (MODEL 6488).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.